Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery

Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study ID
NCT07574762
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Robotic-Arm Assisted Surgery (RA) — DEVICE
    Total Knee Arthroplasty (TKA) performed using a robotic-arm-assisted system connected to navigation software. Like the navigation group, this arm utilizes the personalized alignment strategy and the Attune® CR prosthesis. Instead of manual cutting guides, the surgeon manipulates a robotic arm equipped with a motorized saw to perform the bone cuts according to the pre-planned digital model. This technology is intended to increase the precision of bone resections.
  • Computer-Assisted Navigation (CAN) — DEVICE
    Total Knee Arthroplasty (TKA) performed using an intraoperative computer navigation system. The procedure follows a personalized alignment strategy (restricted kinematic alignment combined with joint stability). After creating a digital model of the knee and mapping anatomical landmarks, the navigation system assists the surgeon in manually positioning the bone cutting guides. The primary implant used is the Attune® CR (Cruciate-Retaining) prosthesis with patellar resurfacing.

Study Details

Title: Personalized Total Knee Arthroplasty: Computer-Assisted Navigation vs. Robotic Assistance (CAN-ARD). Summary: Knee osteoarthritis is frequently treated with Total Knee Arthroplasty (TKA). However, approximately 20% of patients remain dissatisfied following the procedure. This study aims to compare two surgical assistance technologies designed to improve prosthetic placement accuracy: Computer-Assisted Navigation (CAN) and Robotic-Arm Assistance (RA). The primary objective is to determine if there is a significant difference in functional outcomes and the "forgotten joint" sensation (measured by the Forgotten Joint Score - FJS) between patients operated on with robotic assistance versus those with traditional navigation at 3, 12, and 24 months post-surgery. The study's hypothesis is that there is no major clinical difference between these two techniques when applied within a personalized alignment strategy.

Key Dates

First listed
May 8, 2026
Start date
Jan 26, 2026
Status verified
May 2026
Primary completion
Sep 1, 2028
Completion
Jan 26, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Robotic
    Patients undergoing Prosthetic knee arthroplasty under robotic assistance
  • Active Comparator: Navigation
    Patients undergoing Prosthetic knee arthroplasty under navigation assistance

Primary Outcome Measure

Forgotten Joint Score (FJS). [ Time Frame: 3, 12, and 24 months postoperatively. ]

Central Contacts

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